Standard Operating Procedure for Managing Complaints and Feedback

Purpose

This SOP outlines the procedures for handling complaints and feedback in clinical trials and clinical studies. The goal is to ensure that complaints and feedback from participants, study personnel, and other stakeholders are addressed promptly and effectively to improve study quality and participant experience.

Scope

This SOP applies to all personnel involved in handling complaints and feedback in clinical trials and clinical studies, including principal investigators, clinical research coordinators, study sponsors, and site staff.

Responsibilities

• Principal Investigator (PI): Ensures complaints and feedback are handled appropriately and takes action on feedback to improve study quality.
• Clinical Research Coordinators: Assist in managing complaints and feedback, including initial assessment and response.
• Site Staff: Report complaints and feedback to the study team and assist in addressing participant concerns.
• Study Sponsors: Provide guidance and support for complaint and feedback management processes.

Procedure

• Receipt of Complaints and Feedback:
  • Receive complaints and feedback from participants, study personnel, and other stakeholders through designated channels (e.g., phone, email, in-person).
• Assessment and Categorization:
  • Assess the nature and severity of complaints and feedback to determine appropriate actions.
  • Categorize complaints and feedback according to study protocols and institutional policies.
• Response and Resolution:
  • Respond to complaints and feedback promptly, respectfully, and transparently.
  • Resolve complaints and feedback according to established procedures, consulting with relevant parties as needed.
• Documentation and Record-Keeping:
  • Document complaints and feedback, including the nature, assessment, response, and resolution.
  • Maintain records of complaints and feedback in a secure and organized manner for future reference.
• Follow-Up and Improvement:
  • Follow up with complainants and those who provided feedback to ensure satisfaction with the resolution.
  • Use feedback and complaints to identify areas for improvement and implement changes as necessary.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Records of complaints and feedback
• Documentation of responses and resolutions

References

• Institutional policies for handling complaints and feedback
• Regulatory guidelines for managing complaints and feedback

SOP Version

Version: 1.0